Biostatistics and epidemiology
Phases of drug development and post-marketing surveillance
Phase 0 to 4 trials, Australian trial approval (CTN and CTA), TGA registration versus PBS listing, and why rare adverse effects only appear after marketing, with the rule of three worked through.
Tier 2Medical sciences concept
Written with AI assistance and fact-checked against the sources below. For exam study, not clinical decisions. How notes are made
At a glance
- A new medicine moves from preclinical work (in vitro and animal pharmacology, toxicology) through phase 1, 2 and 3 trials to registration, then phase 4 post-marketing surveillance.
- Each phase answers a different question. Phase 3 trials show efficacy against common outcomes but are too small and too short to detect rare or delayed harms.
- In Australia, the TGA decides whether a medicine can be supplied (entry on the ARTG). The PBAC decides separately whether it is subsidised on the PBS, on comparative cost-effectiveness.
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Sources
- Australian clinical trial handbookAU/NZTherapeutic Goods Administration
- Black Triangle SchemeAU/NZTherapeutic Goods Administration
- National Statement on Ethical Conduct in Human Research 2023AU/NZNational Health and Medical Research Council, 2023
- ICH E6(R3) Guideline for Good Clinical PracticeInternational Council for Harmonisation, 2025
- If nothing goes wrong, is everything all right? Interpreting zero numeratorsJAMA (Hanley and Lippman-Hand, 1983;249:1743-5)
- Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412New England Journal of Medicine (Suntharalingam et al., 2006)
- Last updated
- 14 November 2026
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